# Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (Text with EEA relevance), Article 55: Investigator's brochure

Extent: E+W+S+N.I.

1. The sponsor shall provide the investigator with the investigator's brochure.
2. The investigator's brochure shall be updated where new and relevant safety information becomes available, and shall be reviewed by the sponsor at least once per year.

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Source: https://www.legislation.gov.uk/eur/2014/536/article/55 (the official version)
Page: https://openlegislation.uk/eu-regulation-2014-536/article-55
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.